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Review of the Policy, Regulatory Mechanisms andAdministration of Biosafety in Eastern and SouthernAfrica: A study of Kenya, South Africa, Malawi andthe ASARECA initiativeOther
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Muraguri, Lois; Jones, R. B. and Freeman, H. A. F. (2003). Review of the Policy, Regulatory Mechanismsand Administration of Biosafety in Eastern and Southern Africa: A study of Kenya, South Africa, Malawi and theASARECA initiative. ICRISAT, Nairobi, Keyna.
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768-2003
A study of Kenya, South Africa, Malawi and the ASARECA initiative
Lois Muraguri
ICRISAT-Patancheru(Headquarters)Patancheru 502 324Andhra Pradesh, IndiaTel +91 40 30713071Fax +91 40 [email protected]
ICRISAT-Niamey(Regional hub WCA)BP 12404Niamey, Niger (Via Paris)Tel +227 722529, 722725Fax +227 [email protected]
ICRISAT-Nairobi(Regional hub ESA)PO Box 39063, Nairobi, KenyaTel +254 20 524555Fax +254 20 [email protected]
ICRISAT-BulawayoMatopos Research StationPO Box 776,Bulawayo, ZimbabweTel +263 83 8311-15Fax +263 83 8253/[email protected]
ICRISAT-BamakoBP 320Bamako, MaliTel +223 2223375Fax +223 [email protected]
ICRISAT-Maputoc/o INIA, Av. das FPLM No 2698Caixa Postal 1906Maputo, MozambiqueTel +258-1-461657Fax [email protected]
ICRISAT-LilongweChitedze Agricultural Research StationPO Box 1096Lilongwe, MalawiTel +265-1-707297/071/067/057Fax [email protected]
The International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) is a non-profit, non-political, international organization for science-based agricultural development. ICRISAT conductsresearch on sorghum, pearl millet, chickpea, pigeonpea and groundnut – crops that support the livelihoodsof the poorest of the poor in the semi-arid tropics encompassing 48 countries. ICRISAT also sharesinformation and knowledge through capacity building, publications and ICTs. Established in 1972, it is oneof 15 Centers supported by the Consultative Group on International Agricultural Research (CGIAR).
Contact information:
About ICRISAT
Visit us at www.icrisat.org International Crops Research Institute for the Semi-Arid Tropics
Acknowledgements
This report is the product of a three-month research assignment commissioned by ICRISAT.Most of the information in this report was collected from personal interviews with key peoplein the agricultural biotechnology sector in South Africa, Malawi, Mozambique and Kenya. Therespondents were from government departments, NARIs, universities and industry.
In South Africa, I would like to thank Muffy Koch, Wynand van der Walt, Graham Thompson,Vincent Volckaert, Wally Green, Blessed Okole, Eugenia Barros, Shadrack Moephuli, MichelleVosges, Gert Willemse, Mark Maistry, Marina Joubert, Helen Malherbe, and Wilna van Rijssenfor their time and useful information.
In Malawi, I would like to thank Jeff Luhanga, Alick Manda, McJones Shaba, Mike Kachedwa,Fred Nyonda, John Ngalande, Lyson Kampira, Aloysius Kamperewera, Aggrey JD Ambali, Mr.Nkoko and Allan Chiyembekeza for their willingness to share their experiences in regulation ofbiotechnology in Malawi. Thanks too to Dr. Calisto Bias, Paulino Munesse, Annabela Zakarius,Paciencia Banze, Guilhermilia Amurane, Maria da Luz Dai Guebuza and Marcos Friere ofMozambique and Francis Nang’ayo, Mr. Macharia, Christopher Ngichabe, Joseph Wekunda,Francis Nthuku and Stephen Mugo of Kenya.
Special thanks too go to Carlos Dominguez, Moses Siambi and Juan Estrada of ICRISAT fortheir hospitality and for providing logistics, which facilitated research in Mozambique andMalawi. Finally, I wish to thank Marion Motari and Rosalynn Gichimo for reading through thedrafts of this report.
Citation: Muraguri, L., Jones, RB and Freeman, HAF. (2003). Review of the policy, regulatorymechanisms and administration of biosafety in eastern and southern Africa. PO Box 39063,Nairobi 00623, Kenya: International Crops Research Institute for the Semi-Arid Tropics.36 pp.
Review of the Policy, Regulatory Mechanisms andAdministration of Biosafety in Eastern and
Southern Africa
A study of Kenya, South Africa, Malawi and the ASARECA initiative
ICRISAT
Prepared for theInternational Crops Research Institute for the Semi-Arid Tropics
Lois Muraguri
November 2003
AcronymsAATF African Agricultural Technology Foundation
ABSF African Biotechnology Stakeholders Forum
ABSP African Biosafety Programme
ARC Agriculture Research Council
ASARECA Association for Strengthening Agricultural Research in East and Central Africa
AU African Union
BIO-EARN Biotechnology East Africa Regional Network
Bio-EROC Biotechnology – Ecological Research and Outreach Consortium
BRICs Biotechnology Regional Innovation Centres
BTA Biotechnology Trust Africa
BTZ Biotechnology Trust Zimbabwe
CBD Convention on Biological Diversity
CIMMYT International Maize and Wheat Improvement Centre
CSIR Centre for Scientific and Industrial Research
EU European Union
GMO Genetically Modified Organism
IARCs International Agricultural Research Centres
IBC Institutional Biosafety Committee
ICRISAT International Crops Research Institute for the Semi Arid Tropics
IPRs Intellectual Property Rights
ISAAA International Service for the Acquisition of Agri-Biotech Applications
KARI Kenya Agricultural Research Institute
KEPHIS Kenya Plant Health Inspectorate Service
LMOs Living Modified Organisms
NARIs National Agricultural Research Institutes
NBC National Biosafety Committee
NCST National Council for Science and Technology
OECD Organisation for Economic Cooperation and Development
R&D Research and Development
SARB Southern Africa Regional Biotechnology Programme
SAC Scientific Advisory Committee
SMMEs Small, medium and micro enterprises
TRIPs Trade Related Aspects of Intellectual Property
UNEP/GEF United Nations Environment Programme/Global Environment Facility
WTO World Trade Organisation
II
CONTENTS
Executive Summary ....................................................................................................... 1
Introduction .................................................................................................................. 2
Definition and scope of biotechnology .......................................................................... 3
Status of agricultural research ...................................................................................... 3
Areas of research .......................................................................................................... 4
Actors involved in biotechnology .................................................................................. 4
Regulation of biotechnology .......................................................................................... 4
International obligations involving biotechnology and biosafety ................................... 4
Table 1: Status of ratification of CBD and CP by study countries ............................ 5Intellectual property ...................................................................................................... 8
National frameworks for the regulation of biotechnology .............................................. 8
Figure 1: The proposed application procedure under the Kenya Biosafety Bill ........ 12Table 2: GMO permits issued by the Registrar under the SA GMO Act ................. 13Figure 2: Total GMO Applications in RSA (Dec 1999 – June 2003) ....................... 13Table 3: Current legislative approaches within ASARECA member countries ......... 15Table 4: Status of biosafety regulation in the study countries................................... 16Figure 3: The current procedure in Kenya for approval of GMO trials .................... 17Figure 4: Decision making process under the South African GMO Act ................... 18
Regional approach under ASARECA ........................................................................... 18
Table 5: Issues addressed by the ASARECA member countries ............................... 19Table 6: Legislative objectives with respect to biosafety .......................................... 20Figure 5: The proposed structure of a regional biosafety system .............................. 21
Institutional arrangements ........................................................................................... 22
Summary and way forward .......................................................................................... 26
References ................................................................................................................... 27
Annex I: List of respondents/interviewees .................................................................. 30
III
1
Executive SummaryThis report summarises the results of a review of the policy, regulatory mechanisms andadministration of biosafety in Kenya, Malawi and South Africa and under the ASARECA regionalinitiative. The report focuses on the current situation and provides insights as to the form thatdevelopments in the area of regulation of biotechnology are likely to take.
The first section is an introduction, which provides the definition and scope of biotechnology asused in this report. It provides a brief status of agricultural research; the areas of research and theactors involved in biotechnology in the study countries. With the exception of South Africa,experimentation in transgenic crops is still under development. Most of the current agriculturalbiotechnology R&D activities focus on improving crop productivity. The actors are mainly NationalAgriculture Research Institutes, International Agricultural Research Centres and universities.Private sector involvement is in the form of multinational companies.
The second section discusses the frameworks for the regulation of biotechnology. These includeinternational obligations, regional attempts, as well as national efforts in regulating biotechnology inthe study countries. Regulation at the national level has been in the form of national policies,national strategies and through legislation. In Kenya and in most countries under the ASARECAinitiative, acts of parliament are yet to be enacted. The proposed bill and regulations in Kenya andthe proposed regional regulatory structure under ASARECA are discussed with the aim ofproviding an insight as to the trend regulation in these jurisdictions is likely to take.
The third section is a discussion on institutional arrangements in the field of agriculturalbiotechnology. Who are the institutional actors? What are the synergies? What is the institutionalcapacity in terms of human resources and physical infrastructure? This section also explores thecommercialisation and innovation attempts in the study countries. It examines public perceptionand acceptance of modern biotechnology and ends with a brief mention on intellectual propertyprotection in the study countries. South Africa has a developed institutional structure withimpressive facilities and adequate human resource capacity. Critical mass in modern biotechnologyin the other study countries is yet to be attained. Facilities for experimentation in GM technologyare likewise lacking in Kenya, Malawi and other ASARECA countries.
The fourth section summarises the review and presents the way forward. South Africa is bestplaced to handle applications for testing transgenics such as the rosette-resistant groundnutdeveloped by ICRISAT. A representative from the Malawi biosafety committee should be involvedin the testing of the groundnuts in RSA as part of a capacity building exercise and also to pave theway for the testing of the groundnuts in Malawi. In Kenya, there are indications that once an eventis approved elsewhere, it is likely to receive timely approval subject to any additional testing thatthe National Biosafety Board may deem necessary. ICRISAT would have to collaborate with theKARI Institutional Biosafety Committee through which the application to the National BiosafetyCommittee would be made.
Background to the study
This report aims to provide an overview of the status of biosafety policy, laws and regulations, andimplementation issues in Kenya, South Africa and Malawi and under the ASARECA initiative. It isthe product of a three-month research assignment commissioned by ICRISAT.
ICRISAT has made significant strides in modern biotechnology research. Of particular relevanceto this study is the development of transgenic rosette resistant groundnuts, which await testing.The development of transgenic Bt pigeon pea and soybean trypsin inhibitor is at an advanced stage.
2
Until recently in Africa, traditional biotechnology (tissue culture and use of molecular markersfor breeding and selection) has been the only form of biotechnology used to improve agriculturalproduction. These traditional biotech methods do not require national approval forimplementation. Due to potential risks to human health and to the environment, products ofmodern biotechnology are subject to biosafety laws and require individual approval before they canbe tested, deployed and used in a country.
This study seeks to provide the background information on biosafety necessary before the testingand deployment in Africa of transgenic crops developed by ICRISAT.
Methodology
The information in this report was mainly from interviews with key individuals in the field ofbiotechnology and biosafety. These were sampled by identifying the institutions, organisations,government departments and companies whose work is directly involved in the regulation orapplication of biotechnology and biosafety in their respective countries. This information wassupplemented with library and archival material available from the interviewees, the internet andother information in the form of reports and reviews published from previous studies. Annex Icontains the list of interviewees.
Introduction
The application of biotechnology in agriculture offers a wide range of potential benefits directlylinked to addressing food insecurity in Africa. It has the potential of greatly improving foodproduction, food quality and alleviating poverty. In a continent with increasing population anddecreasing arable land, the role of biotechnology in addressing food needs cannot be gainsaid.
In addition to the benefits that agricultural crops improved through genetic engineering bring,these same crops also raise concerns about their potential long-term effects on human health andthe environment. Such concerns have formed the basis for the development and implementation ofguidelines on the safe application of biotechnology. There have been international, regional andnational initiatives at developing biosafety systems.
At the international level, biosafety emerged as a global priority in Agenda 211 and was furtherenshrined in the Convention on Biological Diversity (CBD)2. Protracted negotiations following theadoption of the CBD resulted in the Cartagena Protocol on Biosafety3. This was opened up forsignature in 2000 and came into force on 11th September 2003.
At the national level, countries have made efforts to establish national biosafety systems. Thesesystems are under development in virtually all countries in Africa. Components of a biosafetysystem include a policy, legislation, regulations and guidelines and a strategy to implement thepolicy. Equally important in a biosafety system are institutional arrangements and otherimplementation mechanisms. These elements work in concert to produce a system that ensures thesafe application of biotechnology.
1. Agenda 21 is a plan of action for sustainable development. It was adopted by the international community at the 1992 Earth Summitin Rio de Janeiro. Agenda 21 was a landmark achievement, incorporating environmental, economic and social concerns into a singleframework.
2. Convention on Biological Diversity, (1992), 31 ILM 818 (hereinafter CBD), available at http://www.biodiv.org/3. Cartagena Protocol on Biosafety to the Convention on Biological Diversity, available at http://www.biodiv.org/doc/legal/cartagena-
protocol-en.pdf
3
Regional initiatives have helped facilitate the development of national biosafety systems byproviding technical assistance and fora for the exchange of information among countries. Currentlycountries in Eastern Africa under the Association for Strengthening Agricultural Research in East andCentral Africa (ASARECA) have developed templates on which national biosafety systems can bedeveloped. This ensures uniformity of policies and guidelines, which provides other added benefits.
This study aims at analysing the current status of the biosafety environment in Kenya, South Africa,and Malawi. It will examine national policies, legislation and institutional arrangements in regulatingbiotechnology in each of the three countries. The study will likewise examine regional initiatives in thedevelopment of biosafety policy, regulations and guidelines under the ASARECA initiative.
Definition and scope of biotechnology
This report uses the OECD (1999) working definition of biotechnology where biotechnologies arethe products namely knowledge, goods and services, arising from the alteration of living or non-living materials through the application of science and technology to living organisms as well asparts, products and models thereof4. The techniques used include fermentation, microbialinoculation of plants, plant cell and tissue culture, enzyme technologies, embryo transfer,protoplast fusions, hybridoma or monoclonal antibody technology and rDNA technologies. Thisdefinition allows for a focus on products arising from the research continuum between traditionaland modern biotechnology.
Status of agricultural research
Biotechnology R&D in the study countries has been ongoing for as long as two decades. SouthAfrica has been involved in biotechnology for over 25 years (Wolson, 2001) while in Kenya,traditional biotechnology, mainly tissue culture, has been used in the production of citrus plantsand pyrethrum under a joint initiative by Kenya Agricultural Research Institute (KARI) and theUniversity of Nairobi since the 1980s (Odame, Mbote and Wafula, 2000). Malawi and countriesunder ASARECA have likewise been involved in tissue culture and molecular breeding for over twodecades. Research and development activities in biotechnology have picked up in the region; thesevary from country to country depending on funding, expertise and experience (Mpande, 2001).
With the exception of South Africa and Kenya, the study countries are yet to engage inexperimentation in transgenic crops. In Africa, South Africa is the most advanced in this field andhas already begun commercialising GM crops. At present, there are at least 500 biotechnologyprojects spread over 7 sectors in South Africa (AfricaBio, 2002). Over 590 applications involvingGMO crops have been received and granted by the registrar of the GMO Act; four GM crops havebeen approved for commercial release5. In comparison, it was not until 2000 that modernbiotechnology in crop production was used in Kenya; currently, five transgenic crops are in variousstages of the approval process by the National Biosafety Committee (BTA, 2002). In Malawihowever, only traditional biotechnology is in use; experimentation in transformation is yet to begin.Despite a systematic trend towards adopting selected biotechnology techniques and processes, theuptake of biotechnology in the subregion and in Africa generally has been slow.
4. This definition is similar to that proposed by Cohen (1999).5. these are (i) insect resistant cotton approved in 1997; (ii) insect resistant maize approved in 1998 (iii) herbicide resistant cotton
approved in 2000; (iv) and herbicide resistant soybean approved in 2001.
4
Areas of research
Most of the current biotechnology R&D activities focus on improving productivity in theagricultural sector (Mpande, 2001). The focus of GMO research and development in South Africaand Kenya are primarily for disease and insect resistance. In Kenya, the modern biotechnologyprojects include development of sweet potato for resistance against the feathery mottle virus,development of Bt Maize, the testing of Bt Cotton and the testing of mosaic resistant cassava. InSouth Africa, considerable attention is being paid to fungal and bacterial diseases, improvingstorage properties of crops, weed control, and yield and quality enhancement (AfricaBio, 2002).
Actors involved in biotechnology
Biotechnology research and development in the study countries is carried out in collaboration withthe National Agriculture Research Institutes (NARIs), International Agricultural Research Centres(IARCs) and universities. The NARIs in the ten ASARECA countries are small and vary in size.Agricultural research systems are an important part of a larger agricultural sector, which, in theECA region, is characterised and dominated by peasant farmers who produce mostly forsubsistence. Their type of agriculture is characterised by rudimentary technology, large post-harvest losses, minimal processing and is severely affected by frequently recurring droughts(ASARECA, 2003a)
With the exception of South Africa, private sector investment in the study countries and inAfrica generally is minimal. Modern biotechnology however, is being driven mainly throughcollaboration between national actors and multinational companies.
Traditional biotechnology in the study countries is based on crops specific to their environment.For example, in Kenya, tissue culture for citrus and bananas has been locally developed to addressspecific constraints in their production. Modern biotechnology on the other hand, is largely basedon technology imported from abroad. In South Africa, in spite of biotechnology being in use for 25years, few local products have been developed. The sectors are largely dependant on importedbiotechnology applications with the focus being on commercialisation and industrialisation(Wolson, 2001).
Regulation of biotechnologyProducts of traditional biotechnology, i.e. tissue culture and molecular breeding have been in use inthe study countries for over two decades. These have not been subject to national approval for theirimplementation. However, with the advent of modern biotechnology, concerns over the potentiallong-term effects of transgenic crops to human health and to the environment have come to thefore. These concerns have formed the basis for the development and implementation of guidelineson the safe application of biotechnology. These have translated into international, regional andnational initiatives at developing biosafety systems.
International obligations involving biotechnology and biosafety
Globally, the advent of modern biotechnology has focused attention on the development ofmeasures to ensure the safe application of biotechnology. Concern over the effect of biotechnologywas expressed as early as 1975 in Asilomar at a meeting of international scientists. The ensuing
5
debates formed the groundwork for the development of guidelines to address the movement ofGenetically Modified Organisms (GMOs) between laboratories, from the laboratories to greenhouses and from the green houses to fields for trial. Additional biosafety strategies were employedin the early 1990s to address commercialisation of GMOs.
The Convention on Biological Diversity (CBD) was adopted in 1992. This is an internationallegally binding convention whose objectives are the conservation of biodiversity, the sustainableutilisation of its components and the fair and equitable sharing of benefits arising out of theutilisation of genetic resources. The CBD makes specific provision for the implementation ofbiosafety measures for the trans-boundary movement of living modified organisms (LMOs)6.
Culminating from the protracted negotiations following the adoption of the CBD was theCartagena Protocol on Biosafety. The Protocol was developed out of the recognition that productsof genetic modification could pose a risk to both human health and to the environment. TheCartagena Protocol requires countries to provide for the safe transfer, handling and use of livingmodified organisms (LMOs) resulting from modern biotechnology that may have adverse effectson the conservation and sustainable use of biological diversity, taking also into account risks tohuman health. It specifically focuses on trans-boundary movement.
The Protocol requires states to establish a national focal point to liase with the Secretariat and toestablish competent authorities responsible for administrative functions. It establishes a BiosafetyClearing House Mechanism as a global information centre and a depository of GMO releaseapprovals, their biosafety assessment, permits, registrations and trans-boundary movement ofLMOs7. Member countries are required to deposit their decisions with the Clearing House andencourage the public to have access to such global information. The Protocol came into force on 11September 2003.
Table 1: Status of ratification of CBD and CP by study countries8
INTERNATIONAL INSTRUMENTS RELATING TO BIOSAFETYCOUNTRIES Convention on Biological Diversity Cartagena ProtocolSouth Africa Ratified 02 November 1995 Acceded 14 August 2003Malawi Ratified 02 February 1994 Signed 24 May 2000Kenya Ratified 26 July 1994 Ratified 24 January 2002Burundi Ratified 15 April 1997 Not signedDR Congo Ratified 12 March 1994 Not signedEritrea Acceded 21 March 1994 Not signedEthiopia Ratified 5 April 1994 Ratified 09 October 2003Madagascar Ratified 4 March 1996 Signed 14 September 2000Rwanda Ratified 29 May 1996 Signed 24 May 2000Sudan Ratified 30 October 1995 Not signedTanzania Ratified 08 March 1996 Acceded 24 April 2003Uganda Ratified 08 September1993 Ratified 30 November 2001
SOURCE: CBD Secretariat
ASAR
ECA
COUN
TRIE
S
6. Article 19(3) ‘The Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including,in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resultingfrom biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity’.
7. Article 208. daily updated version available at http://www.biodiv.org/world/parties.asp?lg=0
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Other relevant international regulatory systems include the European Union Regulations, whichalready have an impact on the study countries. In South Africa for example, companies involved intrade with the EU are required to furnish proof of identity preservation (Wolson, 2001). TheCodex Alimentarius Commission is responsible for the setting of world food safety standards andfor establishing international labelling regulations, which will affect GM foods.
In 1999 the then OAU drafted the African Model Law on Safety in Biotechnology9, which wasintended to be a regional law on the regulation of biotechnology to be implemented in Africancountries. The Model Law was fashioned after the Protocol but specifically included aspects thathad been omitted from the Protocol such as pharmaceuticals, GMO products and the nature ofpublic participation. Although the Model Law was criticized for hindering the development ofbiotechnology in Africa (AfricaBio, 2001), it was endorsed by African leaders, in July 2003, at theAU summit in Maputo.
In 2000, a project under the United Nations Environment Programme and Global EnvironmentFund (UNEP/GEF) was set up to help countries that have signed, acceded or ratified theCartagena Protocol to establish biosafety frameworks10. The project offers funding and expertise tofacilitate the development of national decision making frameworks that consider both the safetyand socio-economic impact of the application of GMOs and their products on a case by case basis.
Relevant to biotechnology, a number of regional biotechnology and biosafety trainingprogrammes in Africa have been conducted. These include:
• Biotechnology East Africa Regional Network (BIO-EARN) funded by the Swedish InternationalDevelopment Agency aims at increasing the institutional and national capacity, facilitatingtechnology development and transfer among others. Twenty-seven trainees have received PhDsunder this programme11. It focuses mainly on Ethiopia, Kenya, Uganda and Tanzania
• The Regional Biosafety Focal Point for Eastern and Southern Africa, established in 1984, aims atassisting member countries establish national biosafety focal points, develop national biosafetyframeworks and create national awareness to biosafety
• African Biotechnology Stakeholders Forum (ABSF) based in Nairobi aims to increase publicawareness of biotechnology and biosafety in the region and ensuring broad consultation aboutbiotechnology implementation in regional communities
• Biotechnology Trust Africa (BTA), also based in Nairobi, is funded by the Dutch Governmentand is aimed at improving IP awareness and protection
• Biotechnology Trust Zimbabwe (BTZ) funded by the Dutch Government and operating fromZimbabwe has surveyed the status of biosafety in East and Southern Africa and set priorities forcapacity building in the two regions. It aims at improving biotechnology applications for Africanfarmers
• Southern African Regional Biotechnology Programme (SARB) funded by USAID for capacitybuilding with the main focus on seven Southern African countries
• The UN Food and Agricultural Organisation (FAO), operating from Harare, focuses on food andfeed safety reviews of GMOs for SSA
• African Biosafety Programme I (ABSP I), funded by USAID and managed by Michigan StateUniversity, focuses on technology transfer and biosafety
9. Assembly of the Head of States and Government Decision No. AHG/Dec. 164, Council of the Minister Decision No. CM/Dec.623, July 2001.
10. For further information see http://www.unep.ch/biosafety/11. www.bio-earn.org
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• ABSP II has similar objectives as ABSP I funded by USAID but managed by Cornell University• Programme for Biosafety (PBS) representing the biosafety part of ABSP funded by USAID• International Service for the Acquisition of Agri-Biotech Applications (ISAAA) aimed at
technology transfer• African Agricultural Technology Foundation (AATF), funded by Rockefeller Foundation and
other donors, aims at facilitating technology transfer to small-scale farmers
At the regional level, the ASARECA Biosafety Project is an example of an initiative aimed atfacilitating establishment of a sub-regional biosafety framework. The project, established in 2002,sought to improve the soundness of the biosafety decision-making process in the region by trainingscientists, members of national biosafety committees and regulators from the ASARECAcountries. The sub-regional approach to education and training was seen to foster theharmonisation of technical criteria and procedures. A process whereby national biosafety focalpoints are to submit biosafety data to ASARECA for review and advice was proposed. This wasintended to leverage sub-regional expertise to provide national decision-makers with sound adviceon applications for the intentional environmental release of biotechnology products.
The process proposed involved the submission of data by the national biosafety focal points to acommittee drawn from a roster of experts from within the sub-region. Advice and recommendationwould be provided for the benefit of all member countries. This process was to particularly benefitcountries that have neither capacity nor the resources to implement biosafety systems on their own.It would also contribute to a consistent approach to the provision of expert advice.
The Project was also to establish a roster of sub-regional scientific and socio-economic expertiseto support biosafety decision-making in the region. It sought to establish a program of biosafetyresearch to address sub-regional risk assessment and risk management knowledge gaps. This was tofacilitate the funding of research that is likely to inform and assist national authorities in makingscience based decisions about the effects on biodiversity of introducing GMOs into theenvironment of another ASARECA member country.
With respect to harmonisation, ASARECA seeks to promote the development of regionaltemplates on related policies, guidelines and procedures within ASARECA countries. Each countryis to model their national policies and legislation along these templates subject to variations to suittheir unique needs. The result is expected to be harmonised biosafety procedures in the region.
The regional approach to regulation of biotechnology was born out of the recognition thatcapacity was lacking in ASARECA countries and that the biosafety review process is costly,repetitive and requires specific trained expertise, which is lacking in most ASARECA countries.Given the scarce resources in the sub-region, the approach aims at ensuring that duplication andoverlap in findings in the sub-region do not occur.
It is proposed that a regional biosafety support service centre and a scientific experts’ committeeto review applications and make recommendations be set up. This would facilitate regional reviewsof applications; provide a platform for regional interaction in biosafety, initiate and monitor regionalbiosafety research, and coordinate with other regional players.
There have been priority-setting initiatives under the biotechnology project. Reports have beenprepared to assist in setting priorities for the biotechnology program12.
12. See Johanson, A & Ives C., 2001, An Inventory of Agricultural Biotechnology for the East and Central Africa Region, AgriculturalBiotechnology Support Programme, Michigan State University and Johanson, A., 2002, Agricultural Biotechnology in theASARECA Region: Priorities for Research, Agricultural Biotechnology Support Programme, Michigan State University
8
Intellectual property
Intellectual property rights (IPRs) form an important component in the practice andimplementation of biotechnology. Intellectual property issues are coming to the fore and countrieswill sooner than later have to address Intellectual Property (IP) under their national laws andpolicies. The Agreement on Trade Related Aspects of Intellectual Property (TRIPs Agreement)under the World Trade Organisation (WTO) requires WTO member countries to formulatelegislation protecting IP. In addition to developing national biosafety systems, countries must alsodevelop concomitant policy, legal and institutional frameworks for the protection of IPRs especiallyin the context of biotechnology.
National frameworks for the regulation of biotechnology
A national biosafety system traditionally consists of a national strategy, national policy, legislation,regulations and guidelines. In most cases, the policy and strategy should precede the legislation,whose implementation would be made possible by the promulgation of regulations and theformulation of guidelines.
National policies
The function of a national policy in any sector is inter alia, to outline the nation’s objectives in theparticular sector. A policy forms the spirit of subsequent national action in the particular and otherrelated sectors.
None of the study countries has a national policy on biotechnology or biosafety. Matters relatedto biotechnology are referred to in policies in other sectors the most common being the Science andTechnology (S&T) policies. Malawi has a comprehensive S&T policy13, which acknowledges thepotential of biotechnology in revolutionising production systems in agriculture and observes thatMalawi has not taken full advantage of the opportunities offered by biotechnology and that therehas been no special effort to further develop national competencies in this emerging technology.Although the Malawi S&T policy does not address biotechnology specifically, it commends thegovernment’s effort to develop a legal framework governing biosafety issues in Malawi. The S&TPolicy lists the strategies to be adopted in order to promote the development of Malawi’s interestsin the field of biotechnology. These are to:• establish and strengthen centres of excellence in specific areas of biotechnology;• increase awareness in biotechnology and its potential impact on socio-economic development
through demonstration and training centres;• intensify the development of the human resource capacity in biotechnology;• establish a national programme of action for promotion and adoption of biotechnology;• establish capacity to monitor and evaluate biosafety issues in the economy; and to• establish programmes of international cooperation in biotechnology.
In South Africa and Kenya, the situation is similar. Issues relating to biotechnology and biosafetyhave generally been addressed in the national science and technology policy. Kenya has a broadscience and technology policy but lacks a specific national policy and legal framework onbiotechnology. Likewise, South Africa does not have a national policy on biotechnology. National
13. The 2002 National Science and Technology Policy
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policies on areas that are related to biotechnology and biosafety such as the environment andagriculture, do not focus much attention on biotechnology and biosafety save for perhaps theNational Policy on the Conservation and Sustainable Use of Biodiversity which expresses the needto adopt measures to regulate the use, handling, transfer and release of GMOs. The 1996 Whitepaper on Science and Technology underscores its role in promoting South Africa’s economy andrecognises its benefits in the improvement of the livelihoods of South Africans. It however, onlyidentifies biotechnology as an area of collaboration both nationally and internationally and acrossvarious partners.
Policy formulation in the area of biotechnology is characterised by ad hoc policy relatedstatements and national pronouncements, which are indicative of the political recognition of theopportunities offered by biotechnology. In the study countries, these pronouncements stop at thatwith the exception of South Africa, which has formulated a biotechnology strategy. This serves as aclear sign of the government’s willingness and commitment to embrace biotechnology.
The lack of a specific biotechnology policy results in ineffective prioritising of needs. This isresponsible for fragmented research since these efforts are not aligned to stipulated nationalpriorities. Biotechnology R&D is therefore evolving in a policy vacuum. This has led tofragmentation and poor communication of the biotechnology R&D agenda among variousstakeholders. For example, most of the biotech initiatives reflect interests of concerned individualsand particular institutions. There are little inter-organisational interactions and modernbiotechnology activities are influenced by institutional preferences and donor funding and are notnecessarily guided by or aligned to national priorities (Anyango and Shiundu, 1999).
While biotechnology advances at a rapid pace in the western world, it has yet to find propergrounding in Africa. The governments in the study countries, save for South Africa, have not played amajor role in facilitating consultation and negotiations among different stakeholders in order to setpriorities for biotechnology R&D. The lack of national priority setting and political will to implementbiosafety reflects a lack of awareness of biotechnology and its impact at all levels beginning with policymakers. In Malawi, lack of resources for organising seminars, awareness campaigns etc was also citedas a major obstacle to the formation of a policy on biotechnology and biosafety.
Efforts are however, underway to develop biosafety policies. In Kenya, the National Council forScience and Technology (NCST) has drafted a national biotechnology policy, which awaitsadoption. The draft Biotechnology Development and Biosafety Policy is to be discussed at astakeholders’ meeting to be held in late 2003.
The draft policy has a wide scope that extends to public awareness, legal framework, intellectualproperty issues, capacity for biotechnology R&D, institutional framework to coordinate biotechefforts, funding, safety issues and protection of indigenous resources and knowledge. The policy isto be presented to the committee of Permanent Secretaries and it is expected that it will beapproved by the end of 2003.
In Malawi, a workshop organised by the Environmental Affairs Department and theBiotechnology-Ecological Research and Outreach Consortium (Bio-EROC) in April 2003 broughttogether biotechnology and biosafety experts and stakeholders with the aim of providing a forumfor the development of a biosafety regulatory framework for Malawi and to draw strategies leadingto the implementation of the Biosafety Act14. The participants agreed that a working group shouldbe constituted comprising representatives from Commerce and Industry, Agriculture, Health,
14. Report on the National Biosafety Regulatory Framework Workshop, Lilongwe, 28 April 2003
10
Labour and Environmental Affairs by 30th September 2003. The working group is to formulateterms of reference for the retention of a consultant to lead the process of developing a biosafety policyfor the country. The consultant should have been engaged by 30th October 2003, submit the first draftby May 2004 and the final draft by August 2004, followed by a stakeholders meeting in September2004. A final Biosafety Policy document is scheduled to be available by October 31st 2004.
Although South Africa has no biotechnology or biosafety policy, there however is a Policy onGMO Consignments in Transit. The aim of the Policy is stated as to serve as a framework topromote the safe transit of GMOs through South Africa. This is especially necessary given the factthat South Africa is often utilised for logistic and shipment of food consignments destined for aid tosouthern African countries during emergencies. These consignments may contain GMOs whoseevents have not been approved in South Africa. The policy lays the requirements and the procedureto be followed in such cases.
National biotechnology and biosafety strategies
Of all the study countries, only South Africa has a National Biosafety Strategy. In spite of SouthAfrica’s long history in the use of biotechnology and the large number of biotechnology-embracingprojects, it was determined that RSA had failed to maximize on the potential of third generationbiotechnology and that very few products and processes were under commercialisation. The limitingfactors were identified as including the lack of infrastructure for R&D, institutional capacity, businesssupport and management for start-up technology companies, lack of technology platforms in S&Tcoordination of policies and programmes, lack of collaboration and funding for innovative ideas. Inresponse to this, the Department of Science and Technology embarked on a study that resulted in thedrafting and gazettement of the National Biotechnology Strategy for South Africa in November 2001.
The Strategy identifies gaps and suggests interventions that can be used to ensure that thepotential of biotechnology is harnessed for the benefit of the economy and to improve thelivelihooods of South Africans. The recommendations are in two categories: new institutionalarrangements and specific actions to be taken by government departments. The strategyrecommends the establishment of a Biotechnology Advisory Committee under the Cabinet’sEconomics Cluster which would be responsible for the implementation of the strategy, thecoordination of biotechnology R&D, and alignment with national priorities.
Different means by which the government can influence the development of biotechnology areidentified in the stragety. These include the legal framework, the funding mechanisms, the creationof new infrastructure and institutional arrangements, and the construction of research capacitythrough appropriate human resource development. Certain interventions from the government arelisted. Key among these is the creation of biotechnology regional innovation centres (BRICs) whichwould serve as nuclei for the development of biotechnology platforms that would address the gapbetween research and innovation, the formation of a National Bioinformatics Network, thepromotion of Public Understanding of Biotechnology, conducting a biotechnology audit of SouthAfrica, and the development of a Biobank.
The South African government has pledged to increase R&D spending from 0.27% to 1% ofnational GDP (Maistry, 2003). The funds are to be channeled into operational objectives asoutlined in the strategy. The Biotechnology Strategies Unit under the Department of Science andTechnology is mandated with the implementation of the strategy through the management of newinstitutional and infrastructural arrangements, coordination of biotechnology research anddevelopment and ensuring that R&D is aligned with national priorities.
11
The implementation of the strategy will no doubt stimulate growth and commercialisation ofbiotechnology in South Africa. The strategy promotes local and foreign investment and the BRICsare likely to aid in raising human capacity levels in biotechnology.
Legal regulatory framework
Under national systems, policy can be implemented in different ways. New legislation can beenacted, existing legislation can be reviewed to accommodate the proposed policy and finally, anon-legislative means such as a ministerial decree can be used. Policy can also be implementedthough a combination of these.
Agricultural biotechnology in the sub-region has focused on the development of new plantvarieties, their derived livestock feed and human food products, and animal vaccines or diagnosticsproduced using modern biotechnology. Ministries of agriculture, health, or the environment havetraditionally regulated the conventional forms of products of these processes. In choosing alegislative approach to implementing biosafety, some countries have chosen to develop newregulations under existing science and technology Acts or Statutes.
This type of legislation was originally designed primarily for the purposes of creating andgoverning research agencies. The implementation of new regulations therefore, must be a two-stepprocess. First the existing legislation must be amended to provide the necessary authority to createsuch regulations, and then the regulations must be drafted and promulgated. As the legislativeamendment requires Parliamentary approval, the risk with this approach is that it may be nearly aslengthy as creating a new Act of Parliament and the accompanying regulations.
Implementing biosafety requires an inspection and enforcement capability normally notprovided for under S&T legislation. Hence there is the need to either create a new inspectionservice for that purpose, which may not be cost effective, or to delegate inspection and complianceenforcement to another agency with those powers for example under the ministries of Agricultureor Environment. Therefore, although adaptation of existing laws avoids the necessity of draftingnew laws, it however can lead to redundancy and bureaucratic delays. It would also require theharmonisation of the different sectoral laws to ensure that they are consistent with the policy. Thismay result in side lining new policy that is to be incorporated in the existing laws.
In most sectors, the norm is to have an enabling statute, implementing regulations and finallyguidelines. The current status on legal regulation of biotechnology in Kenya is a departure from thisnorm. There exists no overarching legal framework for the safe application of biotechnology. Kenyahas not enacted any laws that specifically address biotechnology issues. Biosafety regulations andlegislation are only incidentally incorporated in various sectoral statutes. There has been no attemptto date to harmonize these provisions. In the first place, an overall policy on biotechnology, towhich these scattered provisions are to be aligned, is missing.
The application of biotechnology in Kenya is regulated by the 1998 Regulations and Guidelines.These lack an enabling statute. While non-legislative means such as a ministerial decree are fasterand simpler to issue and are more readily amended or replaced, there are enforcement constraints.Without an enabling statute, the guidelines may lack substance. It is, for example, legally difficultto prosecute one who contravenes the guidelines as they lack the weight and enforcement power ofgovernment regulatory authorities. A good biosafety system must provide for an effectiveenforcement mechanism that will secure the enforcement of rights as provided under the law.
With respect to legislative regulation of biotechnology, the study countries are in different stagesalthough virtually all are yet to develop and implement framework laws and supporting regulations.
12
As mentioned, Kenya does not have legislation on biotechnology or biosafety but has been relyingon the 1998 Regulations and Guidelines.
The Regulations and Guidelines cover research on recombinant DNA, categorized experiments,plant biosafety, quarantine procedures, containment and field experimentation. Other areas suchas the deliberate release of GMOs, the importation of biotechnology products and sanctions toensure compliance with biosafety measures are also addressed.
The regulations describe the steps to be followed to develop a national biosafety system. Thegovernment designated the National Council for Science and Technology (NCST) as the authorityto oversee the coordination and implementation of biosafety Regulations and Guidelines. Itssecretariat, the inter-agency National Biosafety Committee (NBC), draws up policies andprocedures and vets research applications to ensure responsible application of biotechnology inKenya. The NBC has been operational since 1998. Currently, five transgenic crops are in variousstages of the approval process by the NBC.
Statutes which mention certain aspects of biotechnology and biosafety in Kenya include: theAgricultural Produce (Export) Act, Cap 319; the Crop Production and Livestock Act, cap 321; thePlant Protection Act, Cap 324; the Suppression of Noxious Weeds Act, Cap 325; the Seeds and PlantVarieties Act, Cap 326; and the Environmental Management and Coordination Act No. 8 of 1999.
This fragmentation of non-specific provisions on biosafety across various statutes is what existsin Kenya today. Recognizing the need for an overarching legal framework on biotechnology, theNCST constituted a task force to prepare a biosafety bill and draft regulations and guidelines inbiosafety for biotechnology. The draft Biosafety Bill establishes the National Biosafety Authoritywhose functions include formulating and implementing policies, plans and programmes for thedevelopment of biosafety in Kenya; overseeing the formulation of standard provisions governingrights and obligations of biosafety institutions; promoting efficiency in the development ofbiosafety through the establishment of appropriate institutional linkages and promoting andencouraging the use of environmentally friendly technologies.
Figure 1: The proposed procedure for experimenting in genetic transformation under the Kenyan Biosafety Bill
Principal investigator!
#
Appropriate Regulatory IBC Authority
$ %
&National Biosafety Expert working group
Board '
(from Board or co-opted)
Institutional Biosafety Committee
13
1. The applicant submits his proposal to the Institutional Biosafety Committee (IBC)2. The IBC assesses the application and forwards it together with the evaluation to the Board for
further assessment3. On receipt of the application, the Board forms an expert working group4. The working group assesses the proposal and may seek additional information from the applicant.
On completion of the assessment, the working group submits its recommendation to the Board.5. The Board returns its report to the IBC6. The IBC in consultation with the appropriate regulatory agency shall make the changes
recommended by the Board.
In South Africa, the Genetically Modified Organisms Act, No. 15 of 1997 (the GMO Act)regulates biotechnology. The objectives of the Act are to promote the safe application ofbiotechnology, to protect the environment and to provide a risk assessment mechanism. The mostsalient features of the Act include the provision for a multi-ministerial decision-making process, theconducting of independent risk assessments by the scientific experts on a case by case basis and theaccommodation of public input through the invitation for comment on GMO applicationspublished in the print media.
Table 2: GMO permits issued by the Registrar under the SA GMO Act from Dec 1999 to June 20031
Applications 1999 2000 2001 2002 2003
Commodity import 1 6 3 37 4Import 0 50 64 58 19Field trials 2 45 61 50 1Export 0 3 22 36 34Transit 0 0 0 2 1Animal Feed/ Food 0 6 1 17 4General Release 0 1 3 1 1Commodity clearance 0 0 6 4 0Contained use 0 11 1 2 1Greenhouse trials 0 0 2 1 0Commercial planting 0 0 9 11 8TOTAL 3 122 172 219 73
Figure 2: Total GMO Applications under the RSA GMO Act (Dec 1999 to June 2003)
14
A total of about 590 applications from December 1999 to June 2003 have been handled by theRegistrar’s office most being for importing GM materials (see Table 2 and Figure 2).
Other legislation of relevance to biotechnology in food and agriculture in South Africa include:The Environment Conservation Act, No. 73 of 1989; The Foodstuffs, Cosmetics and DisinfectantsAct, No. 54 of 1971; The National Environmental Management Act, No. 107 of 1998; TheAgricultural Pests Act, No. 36 of 1983; The Plant Improvement Act, No. 53 of 1976; AnimalImprovement Act, No. 62 of 1998; and The Plant Breeders’ Rights Act, No. 15 of 1976.
In Malawi, the Biosafety Act was passed by Parliament in October 2002 but it is yet to beimplemented. The scope of the Act extends to the genetic modification of organisms, theimportation, development, production, testing, release, use and application of GMOs as well as theuse of gene therapy in humans and animals15. The Act is to be administered by the Minister incharge of Environmental Affairs assisted by appointed officers whose duties and functions are speltout by the Act16. Efforts are currently underway to implement the Act through the establishmentof the Biosafety secretariat and the appointment of other officers. To date, no applications for GMcrops have been made in Malawi.
Under ASARECA, different countries have approached regulation of biotechnology differently.
Components of a national biosafety framework
The components of a national biosafety framework traditionally include:
(i) an administrative office that coordinates the application process. This office is the entrypoint for all applications relating to GMOs and is usually a government department suchas that charged with matters relating to the environment, agriculture or science and tech-nology.
(ii) a scientific advisory committee with a wide range of scientific expertise to cope with thediversity of case-by-case assessments is essential. This body advises government, indus-try and the public on the safe application of biotechnology. Scientific reviews are carriedout on a case-by-case basis. As such, constitution of the review team needs to be flexible(Koch, 2001).
(iii) the decision-making body which should represent interests of all national sectors. Thedecision-making process should allow for public input and should address socio-eco-nomic aspects regarding to the application of biotechnology.
The national biosafety process should address issues such as biosafety communication, publicparticipation and non-safety issues in order to increase the acceptability of the products of thetechnology by the public. Examples of other issues that should be addressed in biosafety systemsinclude processes and activities: contained GMO research in laboratories and green houses;experimental field trials; commercial scale introduction of GMOs; labelling options; marketing andadvertising of GMOs; products; imports; animals; plants; seeds; livestock feeds; agriculturalcommodities; processed food products; drugs and therapeutic products to name but a few. Table 5and 6 summarise the issues considered necessary in developing biosafety systems in ASARECAcountries.
15. section 316. sections 4, 5 and 6
15
Tabl
e 3: c
urre
nt le
gisla
tive a
ppro
ache
s with
in A
SARE
CA m
embe
r cou
ntrie
s*Ite
mDR
Con
goKe
nya
Mada
gasc
arRw
anda
Suda
nTa
nzan
iaUg
anda
New
GMO-
spec
ificYe
sYe
sYe
sleg
islati
onDr
aft le
gislat
ion ex
ists
Bios
afety
Bill
At th
e dra
fting
Does
the p
ropo
sed
Lega
l auth
ority
unde
rNe
w co
mpete
nt au
thority
:sta
geco
mpete
nt au
thority
Minis
ter of
Agr
icultu
reNa
tiona
l Bios
afety
Autho
rityLik
ely un
der
have
exist
ing in
spec
tion
(und
er M
iniste
r of S
&T)
the M
inistr
yan
d enfo
rceme
nt po
wers?
of S&
TCr
eatio
n of c
ross
mini
steria
lNe
w ins
pecti
on st
affCr
eatio
n of N
ation
alBi
osafe
ty Ad
visor
yBi
osafe
ty Bo
ard
Comm
ittee (
Agric
ultur
e,Mi
xture
of ne
w an
d exis
ting
Envir
onme
nt, H
ealth
)ins
pecti
on ac
tivitie
s.W
ill ex
isting
Inspe
ction
staff
New
Act w
ill su
perse
de al
lleg
islati
on/re
gulat
ions
to be
crea
tedex
isting
affec
ted A
ctsre
quire
amen
ding
to de
legate
autho
rity?
Utilis
e exis
ting l
egisl
ation
Using
the D
ecre
e on
Using
exist
ing`
Using
exist
ingPl
annin
g to u
sewi
th ad
apted
or am
ende
dEn
viron
menta
l Impa
ct (o
nlyDe
crees
(Nati
onal
legisl
ation
(Scie
nce
the U
gand
are
gulat
ions (
relev
ant A
ctsco
vers
impo
rtatio
n)En
viron
menta
l&
Tech
nolog
y Act)
Natio
nal C
ounc
il&
comp
etent
autho
rities
,Bi
ll & D
ecre
esfor
Scie
nce
& the
affec
ted pr
oces
ses
unde
r the
Mini
stry
and T
echn
ology
or pr
oduc
ts)of
Agric
ultur
e)St
atute
Draft
Minis
try of
Env
ironm
ent &
Natio
nal B
iosafe
tythe
Nati
onal
Offic
e for
Regu
lation
s are
Envir
onme
ntpr
epar
edDo
es th
e com
peten
tRe
ceipt
& p
roce
ssing
ofau
thority
have
exist
ingap
plica
tions
inspe
ction
& en
force
ment
powe
rs?No
thing
(yet)
rega
rding
dome
stic d
evelo
pmen
tof
GMOs
Inter
im pr
oced
ures
that
Not a
ware
Guide
lines
onha
ve/w
ill be
put in
plac
eof
any
Bios
afety
and
while
legis
lative
/regu
lator
yBi
otech
nolog
y are
amen
dmen
ts ar
ein
place
(Pre
pare
dpr
ogre
ssing
.by
UNC
ST)
Sour
ce: A
SARE
CA 2
003a
* Info
rmati
on o
n Bu
rund
i, Ethi
opia
and
Eritre
a wa
s not
avail
able
16
Table 4: status of biosafety regulation in the study countriesBasic Regulations & Institutional
Framework Policy Strategy Legislation guidelines frameworkBurundi No No No No No NoDR Congo No No No Draft Bill No NoEritrea No No No No No NoEthiopia No Draft policy under No Draft under No No
preparation preparationKenya Yes Draft Policy No Draft Bill Interim regulations YesMadagascar No No No Using existing No No
decree on EIARwanda No No No Plans to use No No
existing decreeSudan No No No Bill is being drafted No NoTanzania Yes Draft Policy No Using existing Regulations under the Yes
legislation Commission for S&TUganda Yes Draft Biotechnology Policy No No Regulations under the Yes
Draft Biosafety Policy National Council forS&T Interim guidelinesunder preparation
Malawi No No No Yes No NoSouth Africa Yes No Yes Yes Yes Yes
ASAR
ECA
COUN
TRIE
S
Decision making process and the time frame
The process for handling applications for experimentation in GM crops in the study countriesincorporates the three levels mentioned above: the administrative office, scientific review processand the final decision-making. In Kenya, the current process is represented in Figure 3.
From the interviews conducted, time frame A was cited as being the most prone toadministrative delays. The lack of coordination between the IBC and the NBC results in furtherdelay. The review process under the NBC likewise is not always within the stipulated time limit.For example, it took three years to obtain an import permit in the case of the KARI/Monsanto virusresistant sweet potato (KARI, 2001). It may be argued that Kenya developed biosafety regulationsfairly recently and is therefore still acquiring experience. The IRMA project has also experiencedadministrative delays most of which have been within the time frame A (KARI and CIMMYT,2001). Large committee membership in both the IBC and the NBC with diverse professionalbackgrounds that hinder timely convening of meetings has been cited as one of the main reasons foradministrative delays within time frames A and B.
Most interviewees however stated that once the NBC had approved applications, the grant ofimport permits from KEPHIS was within reasonable time.
The Executive Committee meets every six to eight weeks. An applicant must therefore make hisapplication to coincide with this meeting otherwise he may loose a considerable amount of time. Ittakes 90 days to process permits and 180 days for the commercial release of GM crops. Theregistrar however may require additional information or clarification from the applicant. No timelimit is allocated for this process. The effect of this is that applications are subject to administrativedelays. This has led to unpredictability regarding the time taken to grant a permit. The relative lackof expertise among members of the Executive Council coupled with the requirement that amajority of the Scientific Advisory Committee (SAC) be present for the taking of decisions servesto further complicate and prolong the process.
17
Figure 3: The current procedure in Kenya for approval of GMO trials using GMO material constructed abroad
Applicant Time frame*
IBC 3 to 7 months
Consultants NBC Applicant
NBC Secretariat 7
months
Relevant ministries
KEPHIS KBS
Grant of import permit 1 month
Applicant
Trials
*according to the draft Regulations and Guidelines, the NBB (the draft Regulations and Guidelines establish the National Biosafety Board as opposed to theexisting National Biosafety Council; all other references to NBC remain the same) from the date of receipt of the application, shall take a maximum of 30days to acknowledge receipt, 60 days to assess application for correctness of information, 90 days to deliberate on the application, 150 days to informapplicant of the decision and 210 days to confirm the grant of the application.
A
B
C
The approval process takes into account repeat applications; approvals on these can be grantedwithin a week. The SAC does not review applications that have been previously approved.Similarly, an application for a GM crop that has gone through the system in another country and hasbeen approved is likely to be processed more quickly.
The Act has been hailed as one that facilitates for a consultative process. By the time a decisionis made, there has been input from the applicant, the scientific audits from the SAC and itscommittees, the public through the mechanism provided using the print media and from nationalconcerns as tendered by the six ministerial representatives. It has however come underconsiderable attack from the growing anti-biotech groups. Some of the criticisms levelled against itinclude the omission to cover GMO products, the exclusion of the civil society from decision
18
Figure 4: Decision-making process under the South African GMO Act.
InspectorateAppeals
Executive CouncilOne officer from each of the 6 ministries:agriculture, science & technology, environmentalaffairs & tourism, health, labour, trade & industry
Scientific AdvisoryCommittee
National advisory body on allmatters related to GMOs
RegistrarBiosafety Administration
Sits in Dept of Agriculture
Applicant
Public
Scientific Reviewers
making, that public participation is not adequately provided for, that liability is placed on users ofGMOs rather than the developers to name but a few (Mayet, 2001). It should be noted that SouthAfrica has a notable anti-biotech movement and the adoption of GM technology by the public maybe influenced by the information disseminated by both pro and anti-biotech movements. Inaddition to the criticisms levelled against the Act by the anti GM movement, the registrar’s officecharged with the implementation of the Act has likewise been criticized as lacking expertise,experience and capacity.
Regional approach under ASARECA
The Biotechnology industry is a research-intensive industry requiring a lot of financial resources.The high amount of funding required calls for cooperation and the sharing of human, financial andtechnological capital. This is yet to be achieved in ASARECA. Member countries are still in theprocess of setting up national biosafety regimes.
Biosafety review may result in duplication within a region where applications relating to GMOsare made to more than one country in a region. A regional approach in biosafety would minimiseduplication and maximise the cost benefit ratio of the risk assessment process.
Biotechnology relies heavily on knowledge flows between and among those involved in itsapplication. A regional approach to biosafety would facilitate the sharing of information. Existinginformation from risk assessments in other countries need not be repeated. Subsequent countriesentertaining applications for the approval of events would benefit from the information alreadyexisting although they would be free to require further information and assessments to addressbiosafety issues specific to their national needs, socio-economic issues and civil society concerns.
GMOs found to be safe for human food or animal feed in one country are likely to be found tobe safe in other countries. Safety reviewers however owe it to their communities to assess theevents according to the prescribed safety review process. A regional approach to such reviewswould result in a decision endorsed by safety experts in the region thereby making it acceptable inthe various countries forming the region.
19
Tabl
e 5: I
ssue
s add
ress
ed b
y the
ASA
RECA
mem
ber c
ount
ries
ISSU
EKe
nya
Ugan
daTa
nzan
iaEt
hiopia
Mada
gasc
arBu
rund
iSu
dan
Rwan
daEr
itrea
DR C
ongo
Regu
lation
s & gu
idelin
esYe
sYe
sYe
s(Dra
ft)No
NoNo
NoNo
NoNo
Institu
tiona
l fram
ewor
k17Ye
sYe
sYe
sNo
NoNo
NoNo
NoNo
Safet
y mea
sure
sYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
Proc
edur
es of
hand
ling r
eque
stsYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
Regu
lator
y pro
cedu
resD
ev’t &
use o
fYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
natur
al GM
OsIm
porta
tion o
f biot
ech p
rodu
ctsYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
- Lab
orato
ry inf
rastr
uctur
e & pr
actic
esYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
- Con
tainm
ent o
f biot
ech p
rodu
ctsYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
- Com
merci
al re
lease
of G
MOYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
- Noti
ficati
onYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
- Com
plian
ce w
ith th
e reg
ulatio
nsYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
& gu
idelin
es- A
fter r
eleas
e mon
itorin
g and
NoNo
NoNo
NoNo
NoNo
NoNo
feed b
ack m
echa
nism
Guide
lines
Labo
rator
y Res
earch
-Ye
sYe
sYe
sNo
NoNo
NoNo
NoNo
Safet
y lev
els -
Safet
y pre
cauti
ons -
Fast
aid -
Med
ical s
tructu
reCo
ntainm
ent/c
onfin
emen
tYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
(Lab
. Gre
en ho
use,
Field)
Comm
ercia
lisati
on &
Rele
ase
Yes
Yes
Yes
NoNo
NoNo
NoNo
NoIm
porta
tion/
Acqu
isitio
nYe
sYe
sYe
sNo
NoNo
NoNo
NoNo
Sour
ce: A
SARE
CA 2
003b
17M
ost
inst
itut
ions
are
dea
ling
wit
h m
oder
n bi
otec
hnol
ogy
but
do n
ot h
ave
Inst
itut
iona
l Bio
safe
ty C
omm
itte
es.
20
Tabl
e 6: L
egisl
ative
obj
ectiv
es w
ith re
spec
t to
bios
afet
y – ac
tiviti
es an
d pr
oduc
ts fo
r whi
ch re
gulat
ion
is be
lieve
d ne
cess
ary*
Item
DR C
ongo
Keny
aMa
daga
scar
Rwan
daSu
dan
Tanz
ania
Ugan
da
Proc
esse
s and
Act
ivitie
sCo
ntaine
d GMO
rese
arch
in la
bora
tories
and g
reen
hous
esYe
sYe
sYe
sYe
sYe
sYe
sYe
sEx
perim
ental
field
trials
of GM
Os, o
r sma
ll sca
leYe
sYe
sYe
sYe
sYe
sYe
sYe
sen
viron
menta
l intro
ducti
ons
Comm
ercia
l sca
le int
rodu
ction
s of G
MOs i
nto ag
ricult
ure
Yes
Yes
yes
yes
yes
Yes
Yes
Envir
onme
ntal in
trodu
ction
s of g
eneti
cally
mod
ified
Yes
Yes
Yes
Yes
Yes
Yes
Yes
micro
orga
nisms
Labe
lling -
optio
ns: b
ased
on co
nten
t of G
MOs,
Yes
Proc
ess
Proc
ess –
noPr
oces
s – no
Proc
ess –
noPr
oces
s – no
or ba
sed o
n der
ived
from
GMOs
even
thou
gh pr
oduc
t(d
erive
d fro
m)Pr
oduc
t – ye
sPr
oduc
t – ye
sPr
oduc
t – ye
sPr
oduc
t – ye
s do
es no
t con
tain G
MOs.)
– noP
rodu
ct(co
ntains
) – ye
sMa
rketin
g/adv
ertis
ing of
GMO
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sDo
mesti
c Mov
emen
t/Tra
nspo
rt of
appr
oved
prod
ucts
NoNo
NoNo
NoNo
NoPr
oduc
tsIm
ports
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Expo
rtsYe
sYe
sYe
sYe
sYe
sYe
sYe
sAn
imals
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Plan
ts, se
eds
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Lives
tock f
eeds
conta
ining
GMO
sYe
sYe
sYe
sYe
sYe
sYe
sYe
sFe
rtilise
rs co
ntaini
ng G
MOs
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Comm
oditie
s (ag
ricult
ural)
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Proc
esse
d foo
d pro
ducts
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Drug
s and
ther
apeu
tic pr
oduc
tsYe
sYe
sYe
sYe
sYe
sYe
sYe
sMe
dical
devic
esYe
sYe
sYe
sYe
sYe
sYe
sYe
sVe
terina
ry bio
logics
(vac
cines
, diag
nosti
cs, e
tc)Ye
sYe
sYe
sYe
sYe
sYe
sYe
sSo
urce
: ASA
RECA
200
3a*in
forma
tion
on B
urun
di, E
thiop
ia an
d Er
itrea
was n
ot av
ailab
le
21
Although human capacity in biotechnology has been growing in the sub region, critical mass ofexperts in biotechnology and biosafety is yet to be attained. Regional cooperation would enablecountries with low human capacity levels to benefit from collaboration with those countries, whichhave a higher level of biosafety capacity. This applies to laboratory facilities as well.
Proposed regional biosafety structure
A workshop on Biodiversity, Biotechnology and Biosafety for East and Central Africa organised bythe Global Biodiversity Institute, in August 2001, brought together 46 delegates from eightASARECA countries with the aim of considering a structure for a regional biosafety initiative. Theproposed structure is represented in Figure 5 :
Figure 5: The proposed structure of a regional biosafety system
I N D I V I D U A L A S A R E C A M E M B E R C O U N T R I E S
OR Central Regional officeNational Biosafety Office ofIndividual country Advertises & invites
countries to nominateexperts
Composed of experts fromthe ASARECA countries
Review Committee
Performs risk assessment
APPLICANT
Recommendations
A S A R E C A M E M B E R C O U N T R I E S
EACH ASARECA COUNTRY MAKES INDIVIDUAL DECISION
The format of the regional biosafety initiative requires further consultation within the region,especially as each country gains experience with handling biosafety applications, regulation and riskassessment. Many of the responsibilities lie with the national framework but when a functioningregional support structure is in place much of the day-to-day administration and responsibilitycould be transferred to this central office. As of now, countries are still developing their nationalbiosafety frameworks and it will take a while before a regional framework is operational.
22
Institutional arrangementsAny decision to establish a biosafety system must address two important questions: what kind ofinstitutions - research, social, political and economic - should be established to enable a country toengage in the biotechnology industry? Secondly, what capacities are required to assess risks inbiotechnology and to effectively manage those risks?
Institutional actors in biotechnology
The study countries particularly Kenya and South Africa have well-established systems of nationalagricultural research. The NARS are characterized by public goods research, use of conventionaltechnology, and centralised and hierarchical organisation. The institutions in this national systeminclude national agricultural research institutes, academic institutions, NGOs, producerassociations and farmers’ associations and other community based organisations. In South Africa,institutional actors in biotechnology R&D include academic institutions, public researchinstitutions, and industry. Academic institutions constitute the largest group of participants inagricultural biotechnology. They are engaged in both basic and applied research. Public researchinstitutions include science councils such as the CSIR, which have the largest share of funding. InKenya, modern biotechnology is dominated by the Kenya Agricultural Research Institute (KARI),universities and international agricultural research institutes (IARCs).
Industry is however, increasingly taking part in the area of modern biotechnology particularly inSouth Africa and in Kenya. However, it is mainly multinational companies that are involved. InMalawi, there is low representation of private companies and venture capital is non-existent.
Although there is some level of collaboration among the various actors in the study countries, therehas not been full exploitation of organisational synergies. In South Africa, institutional linkages existbetween universities, both local and international, and South African institutions. These linkages arecharacterized by information and material exchange. There are other limited collaborations betweennational research institutes, international organisations, government departments, NGOs and theprivate sector. The need for improved institutional linkages was expressed by those interviewed. Thesituation is similar in Kenya while in Malawi, even in the use and application of traditionalbiotechnology, synergies between those involved have not been developed. As a result, the activitiesare uncoordinated and generation and exchange of information, on which biotechnology so heavilyrelies, is lacking. Given the pervasive nature of biotechnology, a multidisciplinary approach toapplication and regulation of biotechnology is inevitable. This means that there must be collaborationbetween researchers, lawyers, engineers, information technology experts, market researchers,business experts and other professionals. This is yet to be fully achieved in the study countries.
Capacity
Building capacity in biosafety is strategically important to successfully integrate biotechnology intoagricultural research. The successful application of biotechnology requires an adequateinfrastructure, a vital component of which is capacity. Capacity for implementation of biosafetyshould be seen in the broader context of human capacity, financial resources and institutional andinfrastructural capabilities.
The study countries have built human resource capacity in traditional biotechnology over the years.Kenya and South Africa have capacity for tissue culture and marker-assisted biotechnology. Currently,
23
there are numerous projects involving tissue culture and marker assisted technology in Kenya, most ofwhich are being conducted under KARI and departments in national universities (BTA, 2002).
With the exception of South Africa, there is a dearth of capacity for molecular biotechnology andrisk assessment. In Kenya, the majority of scientists have basic scientific knowledge in genetics andmolecular biology, they however lack practical experience to effectively apply their existingknowledge to modern biotechnology (Odame et al., 2000). The biosafety system is yet to attain acritical mass of researchers that is required to engage in molecular transformation technology.
There are a significant number of scientists with postgraduate qualifications in South Africa. In1998, the figure was estimated at 1200 - 20% of which had PhD qualifications and 20% with MSc.degrees (Wolson, 2001). The highest concentration of qualified individuals is found in academicinstitutions. Loss of graduates and staff from the system has however lately been of concern asqualified personnel seek greener pastures in the private sector and abroad. A shortcominghighlighted in the decision making process is that of lack of expertise and capacity in those chargedwith the duty of administration of the GMO Act and among decision-makers in government. InKenya, there are competent officers charged with the administration of the Regulations andGuidelines, however, as the number of proposals increase, additional competent personnel will beneeded to handle applications, make decisions, process reports and perform other informationmanagement tasks. Capacity has to be increased and maintained to address the increasing need asresearch in biotechnology takes off.
Malawi has a low stock of science and technology personnel18. The National Science andTechnology Policy requires Malawi to take significant strides in improving her stock of S&T humanresources. With the exception of the S&T policy, which in any case addresses S&T needs generallyand not biotechnology specifically, government and research institutions in Malawi and in the studycountries do not have specific training strategies for building national capacity in biotechnology,intellectual property rights and biosafety. In Kenya and South Africa, research institutions haveincorporated their training needs within the framework of individual research programmes (Odame et al., 2000), while in Malawi, no institutional strategies for addressing capacity wereidentified. Capacity needs begin from the policy level, through the whole value chain ending withthe end user of the technology. Capacity among policy makers particularly in Kenya, Malawi and inthe ASARECA countries needs to be addressed urgently. Research and Development also lacksadequate trained and skilled persons. Capacity is likewise needed and in auxiliary fields such asintellectual property rights. Similarly, the levels of awareness creation, and the distributive systemall require the input of trained persons.
The level of funding in biotechnology is low in the study countries with the exception of SouthAfrica where there is significant investment in biotechnology. In Kenya, the National BiosafetyCouncil charged with the administration of the Biosafety Regulations and Guidelines does not haveany budgetary support from the government. It is an ad-hoc committee that is financed by theapplicants. In Malawi, lack of financial resources was cited as a major setback in the development ofcapacity and undertaking initiatives for the formulation of the national biotechnology policy andstrategy. Due to lack of sufficient public funds, public institutions rely heavily on international donors.
Venture capital in the study countries has not taken root. In South Africa however, there aresome public and private sources of funding for start-up companies wishing to engage inbiotechnology.
18. The National Science and Technology 2002 estimate S&T personnel at 42 per million of the population against the recommendedminimum target of 200 per million in 1980.
24
Intricately linked to financial resources and capacity is the physical infrastructure to implementbiosafety. Resources such as appropriate facilities and equipment to carry out risk assessment andmanagement are crucial to the implementation of biosafety. In respect to facilities, Kenya hasnumerous labs in the long established KARI stations and in academic institutions. However, asapplications for research and use of modern biotech increase, these facilities will have to beupgraded with more efficient and appropriate biotechnology tools. With regard to modernbiotechnology, a green house to handle GM crops is currently under construction at KARI’sBiotechnology Centre in Nairobi. The green house has a Biosafety Level 2 specification and is aculmination of the maturity of the insect resistant maize project (IRMA) under CIMMYT incollaboration with KARI. It is expected that construction of the green house will be completed bythe end of 2003. The recently launched Biosciences Initiative, a facility that is to be hosted atILRI’s headquarters in Nairobi, will no doubt contribute to increasing the capacity in terms ofhuman resource and in infra structure as labs and other facilities for experimentation in molecularbiotechnology are constructed.
South Africa has the most advanced physical infrastructure for biotechnology in Africa. Thereare specialized and expensive scientific equipment in some institutions. Several institutionsinvolved in biotechnology have well-equipped facilities. An example is the CSIR Bio/Chemtekwhose biotechnology unit boasts comprehensively equipped laboratories for molecularbiotechnology, microbial propagation and plant tissue culture. It has green house facilities fortransgenic crop trials. It offers services in DNA fingerprinting for plant and microbial geneticidentification, characterization and verification, marker assisted selection in crop breedingprogrammes, GMO testing for foodstuffs and tissue culture services. The division has adequatehuman capacity to engage in biotechnology research having about 311 scientists and techniciansabout 40 of whom are senior scientists engaged in genetic transformation. The AgricultureResearch Council (ARC) likely boasts experience and specialised capacity in conducting field trials.
Other constraints in the development of biotechnology include poor infrastructure. Moderncommunication systems are lacking in the study countries with perhaps the exception of SouthAfrica. Biotechnology heavily relies on knowledge flows. Poor information technology - manifestedin underdeveloped modern communication systems, access to email and internet - impedes theacquisition and exchange of necessary and relevant information vital in biotechnology.
Commercialisation and innovation
Among the study countries, only South Africa has achieved the commercialisation ofbiotechnology. In Kenya, the most developed GM crop, the sweet potato for resistance against thefeathery mottle virus developed by KARI and Monsanto, is still at the field trials stage. In Malawi,experimentation of GM crops has not commenced. There is likely to be increasedcommercialisation of biotechnology in South Africa owing to the implementation of the NationalStrategy. The Strategy provides for the formation of BRICs, the National Bioinformatics Network,Public Understanding of Biotechnology, and Biobank among other programmes whose mainobjective or ultimate impact is to facilitate the commercialisation of biotechnology products and toincrease capacity in the same.
Consortia made up of academic institutions, private companies and research councils make upthe BRICs. There are currently 3 BRICs representing specific regions in the country. These BRICsreceive funding from the government. Their goal is to address the gap existing between research
25
and innovation. Research and development, entrepreneurial services, technology platforms,intellectual property management, capacity development and business incubation are emphasised,funded, stimulated and facilitated under the BRICs the result being that viable businesses resultfrom the research and resources available.
Other actors in the South Africa biotechnology landscape with activities likely to influencecommercialisation and innovation include the GODISA programme which aims at increasingeconomic growth and employment creation through the enhancement of technological innovation,improvement in productivity and accelerated international competitiveness of South African small,medium and micro Enterprises (SMMEs). The programme supports an Innovation SupportCentre, a Technology Demonstration Centre, and six Technology Incubators. Plans are underwayfor further funding of more technology incubators.
Venture capital has not taken much root in South Africa. There are however some public andprivate sources of funding for start-up companies wishing to engage in biotechnology. These includeHBD Venture Capital, Bioventures, Brait Private Equity, Support Programme for IndustrialInnovation, Technology and Human Resources for Industry Innovation, Industrial DevelopmentCorporation, Innovation Fund and Catalyst Innovations to name but a few.
Public perception and acceptance of biotechnology
Public awareness and understanding of biotechnology has great implications on the acceptance ofproducts of biotechnology. The public in the study countries is largely unaware of the potentialbenefits and risks of the biotechnology. There is little to no effort by the governments and othersinvolved in biotechnology to educate the public and raise awareness. In Malawi, there have been afew initiatives at addressing the situation mainly championed by Bio-EROC. In South Africa,where there is a growing anti-biotechnology movement, the government has included in itsNational Biotechnology Strategy a Public Understanding of Biotechnology (PUB) programme thataims to promote the understanding of biotechnology by disseminating factual, unbiasedinformation.
Intellectual property
Issues of intellectual property rights (IPRs) are beyond the scope of this report but deserve briefmention. IPRs in agricultural research go beyond the conventional plant variety protectionframework to patent legislation and its coverage of biological materials and processes, as well asissues about the countries’ enforcement capacities. IPRs raise a new and distinct managementchallenge for existing research institutions, since they are generally not well equipped to deal withproprietary knowledge. This is with regard to the lack of negotiating skills and the limitations of theadministrative and bureaucratic systems they have to deal with in the acquisition and protection ofIPRs. At the national level, lack of IP policy, legislation on IP, effective enforcement mechanismsand capacity are some of the constraints that are increasingly impacting on agricultural research andtransfer of technology. Countries must address these issues to fulfil their international obligationsunder the WTO TRIPs Agreement.
South Africa has five acts of parliament addressing intellectual property. These are the Patent,Trademark, Copyright, Registered Designs and Plant Breeders’ Rights Acts. All are administeredby the Department of Trade and Industry with the exception of the Plant Breeders’ Rights Act,which is under the Department of Agriculture. However, this legislation is not clear about
26
biotechnology products and processes (OECD, 2003). The Patent office is a non-examiningoffice. Nevertheless, the courts are considered to deal competently with intellectual propertylitigation (Wolson, 2001). In Malawi, intellectual property legislation comprises the Patents Act,1958, the Registered Designs Act, 1958; the Trade Marks Act, 1958 and the Copyright Act, 1989.In Kenya, biotechnology inventions are protected under the Industrial Property Act, no. 3 of 2001.
In spite of having these statutes, IP protection in the study countries is weak. The general legal,policy and institutional framework for the protection of intellectual property particularly in thecontext of biotechnology is still far from adequate and is straddled with financial, technological andsocio-economic constraints.
Summary and the way forwardWith the exception of South Africa, the regulatory framework for biotechnology is still underdevelopment in the study countries. In Kenya, there is a draft Biotechnology Policy and theBiotechnology Development and Biosafety Bill, both of which are yet to be adopted. There arehowever Regulations and Guidelines which have been in place since 1998. Although lacking theforce of law, these have enjoyed the goodwill of those involved in biotechnology and have facilitatedthe experimentation with genetic material in Kenya. Currently, there are applications involving fivecrops that have been made under these Regulations and Guidelines. They are however also underreview to ensure their consistency with international requirements and with the proposed Bill andPolicy. In Malawi, although there is a Biosafety Act, the implementing structure is not yet in place.Although respondents expressed an eagerness to start processing applications, it may not bepractical at the moment as the biosafety secretariat and other administrative officers are yet to beappointed. South Africa is by far the most advanced in modern biotechnology. There is a workingframework for the testing of GM crops under which numerous applications have been made sincethe implementation of the GMO Act in 1999. Under the ASARECA initiative, efforts areunderway to develop a regional biosafety framework although emphasis, at this stage, is indeveloping uniform templates along which individual national frameworks are to be modelled. Theregional biosafety framework is still in the conceptual stages. Applicants as of now will have toapply for the testing or commercialisation of GMOs in those countries that have a workingbiosafety framework.
With regard to human resource capacity and facilities, South Africa has the best infrastructure inplace. There are many qualified scientists engaged in modern biotechnology. Institutional linkagesbetween actors although requiring improvement are by far the most advanced in the studycountries. Critical mass of qualified scientists engaging in modern biotechnology is yet to beachieved in Kenya. The same applies to Malawi, which likewise has limited capacity even intraditional biotechnology.
Way forward
Given the efficient framework, the excellent facilities and enough human resource capacity, SouthAfrica is best placed to handle applications for testing the rosette resistant groundnut developed byICRISAT. CSIR Bio/Chemtek boasts comprehensively equipped laboratories and offers services inGMO testing. The ARC has vast experience and capacity in conducting field trials and would bebest placed to take on the testing at the field trial stage.
27
There is indication from Kenya that technologies once approved in South Africa are likely toreceive timely approval although they have to undergo additional testing should the Biosafety Boarddeem it necessary. In the case of Malawi, lack of resources and capacity was cited as being the mainset back to development of a functioning biosafety framework. It may be worth engaging persons inthe biosafety committee in a collaboration where they would be involved in the testing of therosette resistant groundnut in RSA as part of a capacity building exercise. These persons wouldsubsequently import that knowledge to the biosafety system in Malawi and would serve as a linkwith the ICRISAT application when it is made in Malawi. In the case of Kenya, ICRISAT will haveto collaborate with the KARI Institutional Biosafety Committee (IBC) through which theapplication to the National Biosafety Committee is to be made.
With regard to procedural aspects, the application process in South Africa is relatively shorterthan that in Kenya. However, the time taken for conducting the laboratory tests, experimentationunder contained facilities, confined field trials and national field trials could take as much as 10years and would be a costly exercise. ICRISAT will have to take this into account in determining ifsuch an investment is worthwhile.
Other aspects such as the social and economic impacts, which are beyond the scope of this studyshall also have to be taken into account as these have implications on the deployment andacceptability of the GM crops in the market. Public awareness and matters relating to sensitisingfarmers and their communities have to be considered.
References
AfricaBio, 2001 AfricaBio Submission on the OAU Model Law on Biosafety at http://www.africabio.com/policies/Submission/AU/Model/Law/on/Biosafety/by/AfricaBio.htm
Africa Bio, 2002 South Africa: Status and Future Prospects of Biotechnology available at http://www.africabio.com/status/statusf.htm
Anyango B, and P Shiundu, 1999 Institutional Arrangements towards Biotechnology Policy Making in KenyaPaper prepared for Biotechnology and Public Policy Training Course, ACTS, Nairobi, Kenya.
ASARECA, 2003 a Report on Legislative Framework in ASARECA Member Countries.
ASARECA, 2003 b Report on Regulations and Guidelines in ASARECA Member Countries.
ASARECA, 2003 Priority setting for the ASARECA Biotechnology Initiative
Bio-EROC, 2003 Report on the National Biosafety Regulatory Framework Workshop, 28 April, Bio-EROC,Lilongwe, Malawi.
BTA, 2002 Biotechnology Trust Africa Annual Report 1998 – 2000.
Chigogora J, and Chetsanga C, 2001 Experiences on Sub-Regional Cooperation – The Regional Biosafety FocalPoint (RBFP) for Southern and Eastern Africa Region in Mswaka A, Masimbe S, and Muyulwa D, (eds.)Regional Co-operation on Biotechnology and Biosafety in Eastern and Southern Africa: Proceedings of aRegional Workshop on Biotechnology and Biosafety, 16-18 July, Biotechnology Trust of Zimbabwe.
Clover J, 2002 Situation Report: Genetically Modified Foods in the African Context: Behind theSmokescreen of the Current Debate Institute for Security Studies.
IBS-ISNAR, 1999 Assessing the feasibility of a regional initiative on biotechnology for agricultural research inEastern and Central Africa, A study commissioned by ASARECA.
IRMA, 2001 “Creating Awareness on Biotechnology Based Technologies” Report on a workshop held on 28May, Nairobi, Kenya.
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Ives C, and Wambugu F, 2000 Agricultural biotechnology: Current and Future Trends and Implications forAfrica in Jayne T, Argwings-Kodhek G, and Minde I, (eds.) Perspectives on Agricultural Transformation: AView from Africa. New York. Nova Science.
Johanson A, and Ives C, 2001 An Inventory of Agricultural Biotechnology for the East and Central AfricaRegion, Agricultural Biotechnology Support Programme, Michigan State University.
Johanson A, 2002 Agricultural Biotechnology in the ASARECA Region: Priorities for Research AgriculturalBiotechnology Support Programme, Michigan State University.
Kameri-Mbote P, 2002 The Development of Biosafety Regulation in Africa in the Context of the Cartagena Protocol:Legal and Administrative Issues, Review of European Community and International Environmental Law 11(1): 62-73.
KARI and CIMMYT, 2001 Insect Resistant Maize for Africa Annual Report 2000 KARI/CIMMYT IRMAProject, IRMA Project Document No. 4 Nairobi, Kenya.
Koch M, 2001 Regulatory Status and Regional Biosafety Regulatory Mechanism and Administration underASARECA, Paper prepared for ASARECA.
Maistry P, 2003 Modern Biotechnology and Genetic Modification: Bridging the Gap between Business andPractice (on file with author).
Mayet M, 2001 Critical Analysis of Pertinent Legislation Regulating Genetic Modification in Food andAgriculture in South Africa, Report prepared for Biowatch.
Mpande R, 2001 Regional Cooperation in Biotechnology and Biosafety: An Implementation Strategy for theBiosafety Protocol in Mswaka A, Masimbe S, and Muyulwa D, (eds.) Regional Co-operation on Biotechnologyand Biosafety in Eastern and Southern Africa: Proceedings of a Regional Workshop on Biotechnology andBiosafety, 16-18 July, Biotechnology Trust of Zimbabwe, Kadoma, Zimbabwe.
Nderitu C G, 1999 “Kenya: Biotechnology in Africa: Why the Controversy?” Proceedings of an InternationalConference 21-22 October. Consultative Group on International Agricultural Research (CGIAR) and U.S.National Academy of Sciences, Washington, DC.
Nderitu C, and Wafula J, 1998 Agricultural Needs in Sub-Saharan Africa: The Role of Biotechnology in Ives C,and Bedford B, (eds.) Agricultural Biotechnology in International Development. Oxon. CAB International.
Odame H, and Mbote P, 2000 “Agricultural Biotechnology Assessment in Sub-Saharan Africa: A Case Studyof Kenya” Paper prepared for the Regional Workshop on Building National Biotechnology InnovationSystems: New Forms of Institutional Arrangements and Financial Mechanisms, 6-8 December, ACTS,Nairobi, Kenya.
Odame H, Mbote P, and Wafula D, 2000 “Globalisation and the International Governance of ModernBiotechnology: The Implications for Food Security in Kenya” Paper prepared for a project on Globalisationand the International Governance of Modern Biotechnology, under the Globalisation and Poverty Programmefunded by DFID.
OECD, 2003 Accessing Agricultural Biotechnology in Emerging Economies, framework papers from theOECD Global Forum on Knowledge Economy: Biotechnology, Paris 18-19 November 2002.
Paarlberg R, 2000 “Governing the GM Crop Revolution: Policy Choices for Developing Countries”International Food Policy Research Institute.
Rubaihayo P, 2001 Biotechnology and Biosafety in Agricultural Research and Development in ASARECA inMswaka A, Masimbe S, and Muyulwa D, (eds.) Regional Co-operation on Biotechnology and Biosafety inEastern and Southern Africa: Proceedings of a Regional Workshop on Biotechnology and Biosafety, 16-18 July,Biotechnology Trust of Zimbabwe, Kadoma, Zimbabwe.
Thitai G, Mbaya J, Nyangeri J, (eds.) 1996 “Regulations and Guidelines for Safety in Biotechnology forKenya” Proceedings of the National Workshop on Regulations and Guidelines for Safety in Biotechnology forKenya, 11-12 September, Nairobi, Kenya.
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Van der Walt W, 2003 “Practical Implication of Biosafety Regulatory Systems for Africa” (on file with author).
Wambugu F, 2001 Modifying Africa: how biotechnology can benefit the poor and hungry, A case study fromKenya. Nairobi, Kenya.
Webster J, and Koch M, 2001 Sub-Regional Cooperation in Biotechnology in Mswaka A, Masimbe S, andMuyulwa D, (eds.) Regional Co-operation on Biotechnology and Biosafety in Eastern and Southern Africa:Proceedings of a Regional Workshop on Biotechnology and Biosafety, 16-18 July, Biotechnology Trust ofZimbabwe, Kadoma, Zimbabwe.
Wolson R, 2001 “Agricultural Biotechnology Assessment in Sub-Saharan Africa, Country Study: SouthAfrica” Report prepared for the African Centre for Technology Studies.
Legislation, Regulations and other government documents
South Africa
A National Biotechnology Strategy for South Africa, 2001
Policy on GMO Consignments in Transit
Genetically Modified Organisms Act, Act No. 15 of 1997
The Environment Conservation Act, No. 73 of 1989
The Foodstuffs, Cosmetics and Disinfectants Act, No. 54 of 1971
The National Environmental Management Act, No. 107 of 1998
The Plant Improvement Act, No. 53 of 1976
Department of Agriculture, GMO Permits released in 1999
Department of Agriculture, GMO Permits released in 2000
Department of Agriculture, GMO Permits released in 2001
Department of Agriculture, GMO Permits released in 2002
Department of Agriculture, GMO Permits released in 2003
Application for Authorization to import Genetically Modified Organisms
Malawi
The Biosafety Act 2002.
The National Science and Technology Policy 2002.
The Science and Technology Bill 2002.
The Draft Biosafety Guidelines (Department of Environmental Affairs).
Kenya
NCST (2003) The Biotechnology Development and Biosafety Bill
NCST (2003) The Biotechnology Development and Biosafety Policy
NCST (2003) Regulations and Guidelines for Biosafety in Biotechnology in Kenya
Agricultural Produce (Export) Act, Cap 319 Laws of Kenya
Suppression of Noxious Weeds Act, Cap 325 Laws of Kenya
The Crop Production and Livestock Act, cap 321 Laws of Kenya
30
The Environmental Management and Coordination Act No. 8 of 1999 Laws of Kenya
The Plant Protection Act, Cap 324 Laws of Kenya
The Seeds and Plant Varieties Act, Cap 326 Laws of Kenya
Muffy KochConsultantGolden GenomicsBox 30923Kyalami, 1684Tel: +27 11 702 [email protected]
Dr. Graham ThompsonAssistant Director: Plant Protectionand BiotechnologyARC - RoodeplaatVegetable & Ornamental PlantInstitute,Private Bag X293Pretoria, 0001Tel: +27 12 841 9863Mobile: +27 82 805 [email protected]@igs1.agric.za
Dr. Blessed OkoleSpecialist ScientistCSIR Bio/ChemtekP.O. Box 395Pretoria, 0001Tel: +27 12 841 3110Mobile: +27 83 371 2479Fax: +27 841 [email protected]
Dr. Eugenia BarrosDivision Research FellowCSIR Bio/ChemtekP.O. Box 395Pretoria, 0001Tel: +27 12 841 [email protected]
Marina JoubertFoundation for Education, Science& TechnologyTel: +27 12 [email protected]
Vincent VolckaertManaging DirectorSyngenta SeedCo(Pty) LimitedPrivate Bag X60Halfway House 1685Tel: +27 11 541 [email protected]
Wilna van RijssenDepartment of HealthTel: + 27 83 379 [email protected]
Dr. Wynand van der WaltDirector, AfricaBioAfrica BioTel: +27 83 468 [email protected]
Shadrack MoephuliRegistrar: GMO ActDirectorate: Genetic Resources,National Department of AgriculturePrivate Bag X973Pretoria, 0001Tel: +27 12 319 [email protected]
Michelle VosgesAssistant Director: Genetic ControlDepartment of AgriculturePrivate Bag X973 Pretoria, 0001Tel: +27 12 319 [email protected]
Annex I
List of respondents/interviewees
A. South Africa
31
Dr. G.T. WillemseDeputy Director: ConservationManagementDept of Environment & TourismPrivate Bag X447Pretoria, 0001 Tel: +27 12 310 [email protected]
Mark Maistry Biotechnology Strategies UnitDepartment of Science & TechnologyPrivate Bag X894 Pretoria, 0001Tel: +27 12 337 8270Mobile: +27 82 802 [email protected]
Helen Malherbe Programme CoordinatorPublic Understanding of BiotechnologySouth African Agency for Science & TechnologyAdvancementTel: +27 12 392 [email protected]
Wally GreenBiotechnology RegulatoryManager, South AfricaMonsanto South Africa (Pty) LtdP. O. Box 69933Bryanston 2021Tel: +27 11 790 8200Mobile: +27 82 388 [email protected]
B. MozambiqueDr. Calisto BiasNational DirectorInstituto Nacional de InvestigacaoAgronomica (INIA)Box 3658Mavalane, Maputo [email protected]
Paciencia [email protected]
Dr. Marcos FriereAgronomistEduardo Mondlane UniversityP.O. Box 257 MaputoPaulino Munesse, [email protected]@yahoo.com
Annabela [email protected]
Guilhermilia AmuraneMinistry of Environment
Maria da Luz Dai GuebuzaMinistry of Environment
C. Malawi
Dr. LuhangaDeputy DirectorMinistry of Agriculture, Irrigationand Food SecurityP. O. Box 30779Lilongwe, 3Tel: +256 1 789 275Mobile: +256 8 823 [email protected]
Mr. McJones ShabaAssistant DirectorForestry DepartmentTel: +265 1 771 000Mobile: +265 8 841 [email protected]@malawi.net
Mr. John NgalandeForestry DepartmentP. O. Box 30048Lilongwe 3Tel: +256 1 771 [email protected]
Mr. BandaForestry DepartmentP. O. Box 30048Lilongwe 3Tel: +256 1 771 000
Dr. Aloysius KampereweraDeputy DirectorEnvironmental Affairs DeptPrivate Bag 394LilongweTel: +265 1 771 [email protected]
32
Mr. NkokoBioEROCBox 403ZombaTel: +265-1-525-636
Mr. Alick MandaChief Scientific OfficerNational Research Council of MalawiP. O. Box 30745Lilongwe, 3Tel: +256 1 771 550Mobile: +256 8 318 [email protected]
Mr. Mike KachedwaPrincipal Scientific OfficerNational Research Council of MalawiP. O. Box 30745Lilongwe, 3Tel: +256 1 771 550
Mr. Fred NyondaPrincipal Scientific OfficerNational Research Council of MalawiP. O. Box 30745Lilongwe, 3Tel: +256 1 771 550
Mr. Lyson KampiraPrincipal Environmental OfficerEnvironmental Affairs DeptPrivate Bag 394LilongweTel: +265 1 773 379Mobile:+265 9 916 [email protected]
Dr. Aggrey J.D. AmbaliExecutive DirectorBioEROCBox 403ZombaTel: +265-1-525-636Email: [email protected] [email protected]
Dr. Allan Chiyembekeza
D. Kenya
Dr. Christopher NgichabeCo-ordinatorASARECABiotechnology [email protected]
Joseph Wekunda,Biotechnology Trust AfricaP. O. Box 1285 00100NairobiTel: [email protected]
Mr. MachariaChairmanNational Council for Science andTechnologyNairobiTel:+254-20-219420
Dr. Francis Nang’ayoPrincipal Research OfficerKARI Biotechnology CentreP. O. box 57811NairobiTel: [email protected]@yahoo.co.uk
Francis NthukuBiotechnology Trust AfricaP. O. Box 1285 00100NairobiTel: [email protected]
Dr. Stephen MugoIRMA Project ManagerCIMMYTNairobiTel: [email protected]
768-2003
A study of Kenya, South Africa, Malawi and the ASARECA initiative
Lois Muraguri
ICRISAT-Patancheru(Headquarters)Patancheru 502 324Andhra Pradesh, IndiaTel +91 40 30713071Fax +91 40 [email protected]
ICRISAT-Niamey(Regional hub WCA)BP 12404Niamey, Niger (Via Paris)Tel +227 722529, 722725Fax +227 [email protected]
ICRISAT-Nairobi(Regional hub ESA)PO Box 39063, Nairobi, KenyaTel +254 20 524555Fax +254 20 [email protected]
ICRISAT-BulawayoMatopos Research StationPO Box 776,Bulawayo, ZimbabweTel +263 83 8311-15Fax +263 83 8253/[email protected]
ICRISAT-BamakoBP 320Bamako, MaliTel +223 2223375Fax +223 [email protected]
ICRISAT-Maputoc/o INIA, Av. das FPLM No 2698Caixa Postal 1906Maputo, MozambiqueTel +258-1-461657Fax [email protected]
ICRISAT-LilongweChitedze Agricultural Research StationPO Box 1096Lilongwe, MalawiTel +265-1-707297/071/067/057Fax [email protected]
The International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) is a non-profit, non-political, international organization for science-based agricultural development. ICRISAT conductsresearch on sorghum, pearl millet, chickpea, pigeonpea and groundnut – crops that support the livelihoodsof the poorest of the poor in the semi-arid tropics encompassing 48 countries. ICRISAT also sharesinformation and knowledge through capacity building, publications and ICTs. Established in 1972, it is oneof 15 Centers supported by the Consultative Group on International Agricultural Research (CGIAR).
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About ICRISAT
Visit us at www.icrisat.org International Crops Research Institute for the Semi-Arid Tropics